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Quality Specialist

For NDI

Description

Being Part of Our Team:
When the world’s top medical device OEMs and academic institutes need real-time medical instrument navigation, they call NDI. Why? Because no one can rival the accuracy and reliability of optical measurement and electromagnetic tracking solutions. Since 1981 we’ve helped our customers bring tracking technology to image-guided surgery systems and interventions, surgical simulators, advanced medical research, and so much more. Our team members live and work all over the world. Interested in becoming a valued member of the NDI team? We’re growing and looking for great people to join us.

You will be helping to ensure compliance of NDI products and services, and you will perform quality audits of processes across all functional groups, including but not limited to purchasing, engineering, and manufacturing.  As Quality Specialist, you will promote adherence to product regulatory requirements, and all applicable national and international quality system standards. 

What You Will Be Doing:
Support compliance of the Quality Management System, including:

  • Support the implementation and sustainability of the Quality Management System at the Shelburne facility.
  • Support for obtaining QMS compliance
  • Perform and support Internal Quality System Audits
  • Enter and process Corrective and Preventive Actions in our QMS Software.
  • Maintain the QMS Documentation
    • Process Document Change Order from initiation to release on intranet for company access.
    • Ensure all applicable documentation is properly released, organized and maintained.
    • Manage and maintain QMS documentation databases in our QMS Software.
    • Study and report on data as required.
  • Pull and process all equipment requiring calibration either internally or outside Calibration facility.
  • Research and collect all REACH/RoHS certificates as needed to comply with EU and other Regulatory bodies.
    • Maintain the data/certs in Product LifeCycle Management system.
  • Process Non-Conformances /discrepant material reports process in QMS software. 

NDI is committed to achieving excellence in our Quality activities, which is dependent upon the processes, practices and employees of NDI.  Our objective is to maintain a Quality Management System in compliance with ISO 9001, ISO 13485, the US FDA Quality System Regulation as well as any additional regulatory requirements of the markets in which our products are sold.  Employees of NDI are instrumental to our compliance efforts, and are required to understand and comply with the QMS.

The NDS Quality Specialist is responsible for the support, maintenance and enhancement of the Quality Management System used at NDI Shelburne.

 

Jun 24, 2021
What You Will Bring To The Role: The Quality Specialist supports the implementation, maintenance, audit, and continuous improvement of the Quality Management System at the NDI, focusing on the regional office in Shelburne, Vermont. In Addition: Associates Degree in Business or Computer Sciences, and related, or equivalent working experience in the Quality Department. Experience with ISO 9001 and ideally experience with ISO 13485 Internal Auditor training and/or Certified Lead Auditor preferred Strong knowledge of all aspects of quality assurance, including quality systems, process control and process improvement. Good computer and data skills. Ability to use spreadsheets and databases to collect and chart data. Knowledge of statistical data, including ability to set-up and analyze I-MR charts, breakdown of variance and design of experiments, a plus. A passionate and energetic team member with a keen focus on customer and partner satisfaction.
Associates Degree in Business or Computer Sciences, and related, or equivalent working experience in the Quality Department.
Shelburne, VT
Full-Time
This is a full-time position eligible for participation in the Company’s group insurance plan on day one. Our benefit programs support our employees and allow them to balance their personal lives with flexible work hours and environment. NDI offers generous paid vacation, sick time, paid Holidays time and company-wide shut-down. Also, 401k plan with matching contributions by the company and tuition reimbursement program. Two kinds of Medical plans + Dental and Vision coverage on day one of employment. The company pays for Basic Life Insurance & AD&D and Short Term/Long Term Disability. After you have been an employee for 6 months you are eligible to participate in the Employee Stock Purchase Plan.
Apply online at https://recruiting.ultipro.com/ROP1001ROPER/JobBoard/fe143739-d521-4f49-a596-553671cff63b/OpportunityDetail?opportunityId=03b878fa-97f9-480e-b94c-fb0c3b147fba